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510(k) Data Aggregation
(100 days)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N) The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) premarket notification for a Disposable Medical Mask. It is for a physical medical device (mask), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) are not applicable here.
However, I can extract information related to the acceptance criteria and non-clinical testing performed for this medical mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Performance testing to demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass: 32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $>98%$ |
| Bacterial Filtration Efficiency (ASTM F2101) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $99.9%$ |
| Differential Pressure (EN 14683 Annex C) | Performance testing to demonstrate functionality | $<5.0mmH2O/cm²$ | Pass: $<4.0mmH2O/cm²$ |
| Flammability (16 CFR 1610) | Performance testing to demonstrate functionality | Class 1 | Pass: Class 1 |
| Cytotoxicity (ISO 10993-5) | Safety testing to demonstrate safety of the subject device | Non-cytotoxic | Pass: Device is non-cytotoxic |
| Irritation (ISO 10993-10) | Safety testing to demonstrate safety of the subject device | Non-irritating | Pass: Device is non-irritating |
| Sensitization (ISO 10993-10) | Safety testing to demonstrate safety of the subject device | Non-sensitizing | Pass: Device is non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples per lot, tested across 3 non-consecutive lots.
- Other Performance and Biocompatibility Tests: Specific sample sizes are not explicitly stated for individual tests other than Fluid Resistance, but are implied to be sufficient for standard test protocols outlined by the referenced ASTM and ISO standards.
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications and complied with listed standards. The data provenance is internal testing performed by the manufacturer (Hubei Wanli Protective Products Co., Ltd.) or contracted laboratories adhering to international standards. The document does not specify country of origin for the test data as it pertains to clinical data, but rather product manufacturing. The testing conducted is non-clinical performance and biocompatibility testing. The data is most likely prospective testing for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable as the device is a physical medical mask, and the "ground truth" for its performance is established through standardized laboratory testing against objective criteria (e.g., filtration efficiency percentages, pressure differentials, biocompatibility assays), not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication Method for the Test Set
Not applicable. As above, this is laboratory performance and biocompatibility testing, not human review requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical mask, not an AI-powered diagnostic device. No human reader studies (with or without AI assistance) were conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical mask. The concept of an "algorithm" or "human-in-the-loop performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE, ISO 10993 for biocompatibility). The results are compared against predefined numerical acceptance criteria.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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